Dysautonomia International

Biologically-Adapted, Dose-Escalated Radiotherapy for the Treatment of Ewing Sarcoma, BEAR Trial

Purpose

This clinical trial evaluates the effect of radiotherapy doses based on tumor size and tumor-specific characteristics (biologically-adapted) in treating patients with Ewing sarcoma. Radiotherapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Conventional radiotherapy uses minimal imaging support to determine the positioning of radiotherapy. Hypofractionated radiotherapy delivers higher doses of radiotherapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Dose-escalated radiotherapy uses doses that are higher than those used in conventional radiotherapy. Larger tumor sizes and other tumor-specific characteristics have been shown to be related to poorer outcomes. In addition, after dose-escalated radiotherapy, patients with larger tumors have demonstrated improved control of the disease at the primary tumor site. Giving biologically-adapted, dose-escalated radiotherapy may reduce the return of the cancer at the primary tumor site in patients with Ewing sarcoma with large tumors and other unfavorable characteristics. This clinical trial also evaluates the role of biomarkers in patients with Ewing sarcoma. Studying samples of blood and tumor tissue from patients with Ewing sarcoma in the laboratory may help doctors learn more about predicting the amount of disease and the likelihood of the cancer coming back.

Conditions

Ewing Sarcoma
Round Cell Sarcoma With EWSR1-non-ETS Fusion

Eligibility

Eligible Ages: Over 2 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

PRE-REGISTRATION: INCLUSION CRITERIA - Histological confirmation of Ewing sarcoma, including both skeletal and extra-skeletal primary tumors. Patients with "Ewing-like" sarcoma may be eligible if patients are planned to be treated per Ewing treatment paradigms, as defined in this clinical trial REGISTRATION: INCLUSION CRITERIA - Patients of age ≥ 2 years are eligible for the study - Lansky or Karnofsky performance status ≥ 70 - Ability to provide written informed consent and complete questionnaire(s) by themselves or with assistance - Willing to provide blood samples for correlative research purposes - COHORT A ONLY: Willing to provide biopsy sample to run Mayo Complete Solid Tumor Panel

Exclusion Criteria

REGISTRATION: EXCLUSION CRITERIA - Prior chemotherapy or radiotherapy that, in the opinion of the treating medical oncologist or radiation oncologist, is considered to interfere with the current treatment or measurement of outcomes - Receiving any investigational agent which would be considered as a treatment for the primary neoplasm that is considered by the investigator to interfere with the current treatment or measurement of outcomes - Note: Co-enrollment on another clinical trial is allowed per the treating radiation oncologist's discretion - Other active malignancy ≤ 1 year prior to registration that is considered by the investigator to interfere with the current treatment or measurement of outcomes - Patients that have severe co-morbid systemic illness or other disease which would interfere significantly with the current treatment or measurement of outcomes - Patients that have active uncontrolled systemic infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness or social situation that would limit study adherence - Any of the following: - Pregnant patients - Nursing patients

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Cohort A Group 1 (dose-escalated radiotherapy)	Patients may receive SOC chemotherapy every 2 weeks for at least 3 cycles prior to radiotherapy. Patients then undergo hypofractionated or conventional dose-escalated radiotherapy daily, excluding weekends and holidays, for 25-36 treatment fractions in the absence of disease progression or unacceptable toxicity. Patients may also receive consolidation chemotherapy after completion of radiotherapy and/or surgical resection. Patients also undergo blood sample collection throughout the study. Additionally, patients may also undergo CT, PET/CT, and MRI with or without CT throughout the study at treating clinician's discretion.	Procedure: Biospecimen Collection Undergo blood sample collection Other names: Biological Sample Collection Biospecimen Collected Specimen Collection Drug: Chemotherapy Given chemotherapy Other names: Chemo Chemotherapy (NOS) Chemotherapy, Cancer, General Procedure: Computed Tomography Undergo CT or PET/CT Other names: CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography Computerized Tomography (CT) scan CT CT Scan Diagnostic CAT Scan Diagnostic CAT Scan Service Type tomography Procedure: Conventional Radiotherapy Undergo conventional radiotherapy Other names: 2-Dimensional Conventional Radiation Therapy 2D Conventional Radiotherapy 2D Radiotherapy 2D-RT Radiation, 2D Conventional Procedure: Definitive Surgical Resection Undergo definitive surgical resection Radiation: Dose-escalated Radiation Therapy Undergo hypofractionated or conventional radiotherapy Other names: Dose-escalated RT Other: Electronic Health Record Review Ancillary studies Radiation: Hypofractionated Radiation Therapy Undergo hypofractionated radiation therapy Other names: Hypofractionated Hypofractionated Radiotherapy hypofractionation Radiation, Hypofractionated Procedure: Magnetic Resonance Imaging Undergo MRI Other names: Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI Procedure: Positron Emission Tomography Undergo PET/CT Other names: Medical Imaging, Positron Emission Tomography PET PET Scan Positron emission tomography (procedure) Positron Emission Tomography Scan Positron-Emission Tomography PT Other: Questionnaire Administration Ancillary studies
Experimental Cohort A Group 2 (standard dose radiotherapy)	Patients may receive SOC chemotherapy every 2 weeks for at least 3 cycles prior to radiotherapy. Patients then undergo hypofractionated or conventional standard dose radiotherapy daily, excluding weekends and holidays, for 25-31 treatment fractions in the absence of disease progression or unacceptable toxicity. Patients may also receive consolidation chemotherapy after completion of radiotherapy and/or surgical resection. Patients also undergo blood sample collection throughout the study. Additionally, patients may also undergo CT, PET/CT, and MRI with or without CT throughout the study at treating clinician's discretion.	Procedure: Biospecimen Collection Undergo blood sample collection Other names: Biological Sample Collection Biospecimen Collected Specimen Collection Drug: Chemotherapy Given chemotherapy Other names: Chemo Chemotherapy (NOS) Chemotherapy, Cancer, General Procedure: Computed Tomography Undergo CT or PET/CT Other names: CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography Computerized Tomography (CT) scan CT CT Scan Diagnostic CAT Scan Diagnostic CAT Scan Service Type tomography Procedure: Conventional Radiotherapy Undergo conventional radiotherapy Other names: 2-Dimensional Conventional Radiation Therapy 2D Conventional Radiotherapy 2D Radiotherapy 2D-RT Radiation, 2D Conventional Procedure: Definitive Surgical Resection Undergo definitive surgical resection Other: Electronic Health Record Review Ancillary studies Radiation: Hypofractionated Radiation Therapy Undergo hypofractionated radiation therapy Other names: Hypofractionated Hypofractionated Radiotherapy hypofractionation Radiation, Hypofractionated Procedure: Magnetic Resonance Imaging Undergo MRI Other names: Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI Procedure: Positron Emission Tomography Undergo PET/CT Other names: Medical Imaging, Positron Emission Tomography PET PET Scan Positron emission tomography (procedure) Positron Emission Tomography Scan Positron-Emission Tomography PT Other: Questionnaire Administration Ancillary studies Radiation: Radiation Therapy Undergo hypofractionated or conventional standard radiotherapy Other names: Cancer Radiotherapy Energy Type ENERGY_TYPE Irradiate Irradiated Irradiation Radiation Radiation Therapy, NOS Radiotherapeutics Radiotherapy RT Therapy, Radiation
Experimental Cohort B (definitive radiotherapy, surgical resection)	Patients may receive SOC chemotherapy every 2 weeks for at least 3 cycles prior to radiotherapy. Patients with tumor size < 8cm at diagnosis undergo definitive radiotherapy or surgical resection. Patients may also receive consolidation chemotherapy after completion of definitive radiotherapy or surgical resection. Patients also undergo blood sample collection throughout the study. Additionally, patients may also undergo CT, PET/CT, and MRI with or without CT throughout the study at treating clinician's discretion.	Procedure: Biospecimen Collection Undergo blood sample collection Other names: Biological Sample Collection Biospecimen Collected Specimen Collection Drug: Chemotherapy Given chemotherapy Other names: Chemo Chemotherapy (NOS) Chemotherapy, Cancer, General Procedure: Computed Tomography Undergo CT or PET/CT Other names: CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography Computerized Tomography (CT) scan CT CT Scan Diagnostic CAT Scan Diagnostic CAT Scan Service Type tomography Procedure: Definitive Surgical Resection Undergo definitive surgical resection Other: Electronic Health Record Review Ancillary studies Radiation: External Beam Radiation Therapy Undergo definitive radiotherapy Other names: Definitive Radiation Therapy EBRT External Beam Radiation External Beam Radiotherapy External Beam Radiotherapy (conventional) External Beam RT external radiation External Radiation Therapy external-beam radiation Radiation, External Beam Teleradiotherapy Teletherapy Teletherapy Radiation Procedure: Magnetic Resonance Imaging Undergo MRI Other names: Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI Procedure: Positron Emission Tomography Undergo PET/CT Other names: Medical Imaging, Positron Emission Tomography PET PET Scan Positron emission tomography (procedure) Positron Emission Tomography Scan Positron-Emission Tomography PT Other: Questionnaire Administration Ancillary studies
Experimental Cohort C (radiotherapy, surgical resection)	Patients may receive SOC chemotherapy every 2 weeks for at least 3 cycles prior to radiotherapy. Patients undergo radiotherapy before or after undergoing definitive surgical resection. Patients may also receive consolidation chemotherapy after completion of definitive radiotherapy and surgical resection. Patients also undergo blood sample collection throughout the study. Additionally, patients may also undergo CT, PET/CT, and MRI with or without CT throughout the study at treating clinician's discretion.	Procedure: Biospecimen Collection Undergo blood sample collection Other names: Biological Sample Collection Biospecimen Collected Specimen Collection Drug: Chemotherapy Given chemotherapy Other names: Chemo Chemotherapy (NOS) Chemotherapy, Cancer, General Procedure: Computed Tomography Undergo CT or PET/CT Other names: CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography Computerized Tomography (CT) scan CT CT Scan Diagnostic CAT Scan Diagnostic CAT Scan Service Type tomography Procedure: Conventional Radiotherapy Undergo conventional radiotherapy Other names: 2-Dimensional Conventional Radiation Therapy 2D Conventional Radiotherapy 2D Radiotherapy 2D-RT Radiation, 2D Conventional Procedure: Definitive Surgical Resection Undergo definitive surgical resection Other: Electronic Health Record Review Ancillary studies Radiation: External Beam Radiation Therapy Undergo definitive radiotherapy Other names: Definitive Radiation Therapy EBRT External Beam Radiation External Beam Radiotherapy External Beam Radiotherapy (conventional) External Beam RT external radiation External Radiation Therapy external-beam radiation Radiation, External Beam Teleradiotherapy Teletherapy Teletherapy Radiation Radiation: Hypofractionated Radiation Therapy Undergo hypofractionated radiation therapy Other names: Hypofractionated Hypofractionated Radiotherapy hypofractionation Radiation, Hypofractionated Procedure: Magnetic Resonance Imaging Undergo MRI Other names: Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI Procedure: Positron Emission Tomography Undergo PET/CT Other names: Medical Imaging, Positron Emission Tomography PET PET Scan Positron emission tomography (procedure) Positron Emission Tomography Scan Positron-Emission Tomography PT Other: Questionnaire Administration Ancillary studies Radiation: Radiation Therapy Undergo hypofractionated or conventional standard radiotherapy Other names: Cancer Radiotherapy Energy Type ENERGY_TYPE Irradiate Irradiated Irradiation Radiation Radiation Therapy, NOS Radiotherapeutics Radiotherapy RT Therapy, Radiation

Recruiting Locations

Mayo Clinic in Rochester
Rochester, Minnesota 55905

Contact:
Clinical Trials Referral Office
855-776-0015
mayocliniccancerstudies@mayo.edu

More Details

Status: Recruiting
Sponsor: Mayo Clinic

Study Contact

Clinical Trials Referral Office
855-776-0015
mayocliniccancerstudies@mayo.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.